Novel wound irrigation device and method

ABSTRACT

The subject invention provides novel, inexpensive, and highly effective methods and devices for convenient and effective wound irrigation. In one embodiment the subject invention provides a discharge means for a reservoir housing containing irrigation solution wherein the discharge means has one or more specifically designed nozzles through which a sufficient volume of the irrigation solution can pass at an appropriate pressure.

CROSS-REFERENCE TO A RELATED APPLICATION

This application claims the benefit of provisional patent applicationSer. No. 60/504,767, filed Sep. 22, 2003, which is hereby incorporatedby reference in its entirety.

BACKGROUND OF THE INVENTION

In the management and treatment of a wound there are three primaryobjectives: (1) prevention of infection, (2) preservation and/orrestoration of function, and (3) preservation and/or restoration ofcosmetic appearance. The most important of these objectives is theprevention of infection. Success in the prevention of infection directlyaffects the healing process and the degree to which the other twoobjectives, function and cosmetic appearance, can be preserved and/orrestored.

It is known that the number of bacteria, rather than bacterial type, isa critical determinant of whether a wound becomes infected. Experimentalevidence suggests that a critical level of bacteria is approximately 10⁵organisms per gram of tissue. Below this level, wounds heal; at levelsgreater than 10⁵ bacteria per gram of tissue, wounds often becomeinfected. All traumatic wounds are contaminated by the time the wound ispresented to a medical care facility for treatment (Dire, Daniel I.[1990]) “A comparison of Wound Irrigation Solutions Used in theEmergency Department,” Annals of Emergency Medicine 19(6):704-708).Dirty wounds, or those which have not been treated within six hours, arelikely to be contaminated with bacteria at levels that are higher thanthe critical level. Reducing the number of bacteria in and around thewound is a recognized and accepted means for avoiding infection andexpediting wound healing.

Different procedures of wound management have been developed to helpdecrease the level of bacteria present in a wound, i.e., reduce theincidence of infection. The cleansing of a wound and the sitesurrounding the wound to remove blood clots, debris, dirt, or otherforeign materials that can introduce contaminants, including pathogenicmicroorganisms, is critical in reducing levels of bacteria in and aroundthe wound. There are numerous wound cleansing procedures presently usedby healthcare professionals such as debridement, excision andirrigation. See, for example, Sinkinson, Craig Alan, ed. (1989)“Maximizing A Wound's Potential For Healing,” Emergency Medicine Reports10(11):83-89; Lammers, Richard L. (1991) “Soft Tissue Procedures:Principles of Wound Management,” in Clinical Procedures in EmergencyMedicine, Roberts and Hedges, eds., 2nd Ed., W. B. Saunders Company, pp.515-521; Cracroft, Davis (1987) “Minor Lacerations and Abrasions,”Emergency Medicine: A Comprehensive Review, Kravis and Warner, eds., 2ndcd., Aspen Publishing Co., pp. 107-110; and Mulliken, John B. (1984)“Management of Wounds,” in Emergency Medicine, May ed., John Wiley &Sons, pp. 283-286.

Irrigation is the most commonly used procedure for cleansing of opencontaminated wounds. Irrigation involves the application of sterilesolutions or fluids to wounds to remove loose devitalized tissue,bacterial inoculum, blood clots, loose debris, and foreign bodiesproximate to and within the depths of the wound. The two criticalcomponents of any effective wound irrigation method and/or device are:(1) the application of an adequate volume of sterile irrigation solutionto the wound, and (2) the use of sufficient pressure applied in aneffective dispersal pattern in the delivery of the solution toeffectively remove contaminants. Regarding volume, the amount ofirrigation solution required will depend upon the type of wound and thelevel of contamination. Injuries which can introduce a high amount ofbacteria into a wound (such as puncture wounds and bites) may require 1liter or more of irrigation solution. See Mulliken, 1989. Regardingpressure, it has been demonstrated that stream pressure of a minimum of4 pounds per square inch (psi) (and, preferably, 7 psi) is required toeffectively flush or remove contaminants from a wound. See, for example,Rodeheaver GT. Wound Cleaning, Wound Irrigation, Wound Disinfection, In:Krasner D., Kane D. Chronic Wound Care. 2^(nd) ed. Wayne, P. A.: HealthManagement Publications; 1997, pp 97-108; and Bergstrom N., Bennett, M.A., Carlson, C. E. et al. Treatment of Pressure Ulcers. ClinicalGuideline No. 15. AHCPR Publication No. 95-0652. Rockville, Md.Department of Health and Human Services. Public Health Services, Agencyof Health Care Policy and Research; December 1994.

Irrigation pressure in excess of desired limits (e.g., 25 psi orgreater) may actually drive bacteria and particulate matter deeper intothe wound and thereby defeat the purpose of the irrigation process.High-pressure irrigation may also cause damage to healthy tissue andimpede the tissue's defenses and retard healing. Thus, effective woundirrigation requires the use and application of adequate volumes ofirrigation solution delivered to the wound in an effective dispersalpattern at appropriate pressures.

Bulb syringes or gravity flow irrigation devices deliver fluid at lowpressures and as such are ineffective in ridding wounds of smallparticulate matter or in sufficiently reducing wound bacterial counts.Irrigation by bulb syringe exerts a pressure of about 0.05 psi, whichdoes not reduce the number of bacteria or particulate contaminantsenough to prevent infection. The flow rate of irrigation fluid deliveredthrough intravenous (IV) tubing can be enhanced by inflation of a bloodpressure cuff around a collapsible plastic IV bag. This method iscumbersome and provides considerably less irrigation pressure than canbe delivered by a plunger-type syringe.

The plunger-type syringe is the most common irrigation device currentlyused. Its use involves filling the barrel of the syringe with sterileirrigation solution and depressing the plunger to generate and apply asingle pressurized stream of solution in and around the wound todislodge and rinse away contaminants. This device has two notabledisadvantages: (1) an extremely limited reservoir of irrigation fluid(typically a syringe with a 35 cc-capacity barrel), and (2) it islimited to dispersal and application of a single concentrated stream ofsolution to the wound. Consequently, in most cases, the syringe must berepeatedly refilled in order to apply sufficient quantities ofirrigation solution to a wound. This is time-consuming and cumbersome todo while attempting to maintain a sterile field. In an attempt toaddress this limitation, a device has been developed that involves asystem consisting of a syringe and IV tubing with a valve system thatattaches to a bottle of saline to provide a ready means of refilling thesyringe barrel. (Travenol pressure irrigation set, code no. 2D2113, orirriget, Ackrad Laboratories, Garwood, N.J.). Additionally, U.S. Pat.No. 4,357,937 describes a disposable, manually operable medicalirrigation device which is adapted for providing selective volume andstream intensity in liquid flow from a plurality of syringes. Thesedevices do not adequately address the disadvantages of using syringesfor irrigation as discussed above and are not commonly used in clinicalpractice due to their complexity of use and cost.

The amount of hydraulic pressure that can be delivered with aplunger-type syringe varies with the force exerted on the plunger of thesyringe and with the internal diameter of the attached needle.Plunger-type syringe devices that deliver moderate pressure employeither a 19 gauge needle attached to a 35 cc syringe, which createshydraulic pressure in the range of 7-8 psi, or a 30 ml syringe fittedwith a 19 gauge needle which typically creates about 7 psi irrigationpressure. A 22 gauge needle attached to a 12 cc syringe, delivers apressure of about 13 psi. Such pressures have been proven effective inwound irrigation, but, as stated above, such devices apply only a singleconcentrated stream of solution to the wound. In addition, thesedescribed devices hold less than adequate volumes of irrigation solutionand therefore require repeated refilling which is time consuming andcumbersome.

U.S. Pat. No. 5,071,104 describes a wound irrigation apparatus andprocess for cleansing wounds which includes a pressure bladder, e.g., ablood pressure cuff, disposed proximate a reservoir holding a cleaningsolution. The device in the '104 patent also includes a flexible tubularconduit for transmitting the solution from the reservoir to a singlenozzle. The conduit and reservoir form a two-part system which is timeconsuming to set up, inconvenient to use, and costly.

U.S. Pat. No. 5,133,701 describes a disposable pressurized woundirrigation device which has a pressurized chamber for providing a forceupon the reservoir such that a single liquid stream of cleansingsolution is expelled from the device at a constant pressure. Apropellant is used in evacuating the cleanser contents of the device.This invention requires a propellant and involves a relatively elaboratemanufacturing and filling process which is labor intensive and requiresspecialized machinery. This device is also inconvenient to use andcostly.

More recently, an advantageous wound irrigation system has beendeveloped whereby a dispersed stream of irrigation fluid is easily andeffectively applied to wounds. This system is described at, for example,U.S. Pat. Nos. 5,830,197 and 6,468,253 and International PatentApplications WO 00/15279 and WO 02/007799. Although the use of thedispersed stream was highly advantageous, it has now been determinedthat the shape and size of the nozzles delivering the irrigation fluidcan be improved to give even better results.

The subject invention successfully addresses the above describeddisadvantages associated with the previously known devices and methods,and provides certain attributes and advantages which have not beenrealized by these known devices.

BRIEF SUMMARY OF THE INVENTION

The subject invention provides novel, inexpensive, and highly effectivemethods and devices for convenient and effective wound irrigation. Inone embodiment the subject invention provides a discharge means for areservoir housing containing irrigation solution wherein the dischargemeans has one or more specifically designed nozzles through which asufficient volume of the irrigation solution can pass at an appropriatepressure for effective wound irrigation.

In a preferred embodiment, the device has a plurality of nozzles thatare specifically designed to reduce the pressure loss as the irrigationfluid leaves the reservoir housing. There are two elements of the designthat are particularly important—the shape of the nozzle and the lengthof the nozzle. Preferably, the nozzle is elongated and comprises aventuri shaped passageway.

In a preferred embodiment, the reservoir housing, upon which a dischargemeans is either permanently or detachably affixed, is compressible(e.g., plastic bottles in which saline solutions are presentlyavailable). The operator (i.e., medical or health care professional orother person) using the subject device and providing wound irrigationtherapy can easily compress the reservoir housing to force theirrigation solution through the nozzle(s) of the discharge means undersufficient pressure to dislodge dirt, debris, or other particles,including microorganisms, e.g., pathogenic bacteria.

Specifically exemplified herein is the use of a plurality of elongatednozzles to achieve the desired dispersal, pressure, and volume of thestream of irrigation solution.

The subject invention provides an easy to use, economical woundirrigation system that is capable of delivering adequate volumes ofirrigation solution (without refilling the reservoir) in a dispersedstream under sufficient pressure to effectively cleanse the wound,thereby reducing the incidence of infection.

In a further embodiment, the subject invention provides a lacerationtray that has items conveniently provided for treating wounds.

In yet another embodiment, the subject invention provides a sterileproduct for use in an operating room.

In yet another embodiment, the subject invention provides a pressurizedirrigation assembly comprising: irrigation solution; a reservoir housingthat contains the irrigation solution; a discharge means having one ormore specifically designed nozzles through which a sufficient volume ofthe irrigation solution can pass at an appropriate pressure; and a meansfor creating pressure for the generation of one or more dispersedstreams through the nozzle(s) to irrigate damaged tissue.

The subject invention allows the operator to, without assistance, easilydirect and control the application of irrigation solution with one hand,leaving the other hand free for other activities, such as separation ofthe wound to further facilitate irrigation.

BRIEF SUMMARY OF THE FIGURES

FIG. 1 shows the subject wound irrigation device that includes acompressible reservoir housing, and a discharge means that has aplurality of nozzles for directing a pressurized stream of irrigationsolution to a wound.

FIG. 2 shows an embodiment of the subject wound irrigation device with aprotective cover.

FIG. 3 shows one embodiment of the subject wound irrigation device.

FIG. 4 shows elongated nozzles of the subject invention.

FIG. 5 shows a specific embodiment of the subject invention.

FIG. 6 shows a venturi shaped nozzle of the subject invention.

DETAILED DESCRIPTION OF THE INVENTION

The subject invention provides novel, convenient, inexpensive, andeffective wound irrigation devices that comprise, in a preferredembodiment, a reservoir housing and a discharge means having one or morenozzles for irrigation of a wound. The subject invention also providesmethods of use for the device.

The materials and methods of the subject invention make it possible toconveniently and easily apply a stream of irrigation fluid to a woundwith the stream having an appropriate volume, pressure, and dispersalpattern. Under optimal circumstances, the wound irrigation devices andmethods of the subject invention are utilized by trained emergencymedical technicians; however, because of the simplicity and convenienceof the devices of the subject invention, they can be used to greatlyenhance the effectiveness of wound irrigation regardless of the traininglevel of the operator performing the irrigation.

In a preferred embodiment, the nozzle(s) of the current invention arespecifically designed to reduce the pressure loss as the irrigationfluid leaves the reservoir housing. There are two elements of the designthat are particularly important—the shape of the nozzle and the lengthof the nozzle. Preferably, the nozzle is elongated and comprises aventuri shaped passageway.

In a preferred embodiment, each nozzle acts a jet through whichirrigation fluid is forced, under pressure, to achieve velocities andpressures appropriate for efficient wound (including eye) irrigation.The nozzles are designed to reduce friction and turbulence andfacilitate achieving sufficient irrigation pressures with minimaloperator effort.

In accordance with the subject invention, it has been determined that anelongated nozzle is preferred. As used herein, reference to the “nozzle”refers to a passage 98 that delivers a stream of irrigation fluid fromthe inside to the outside of a reservoir housing. In accordance with thesubject invention, the nozzle is preferably longer than about 0.005inches (from inlet port 102 to outlet port 96). More preferably, thenozzle is longer than about 0.01 inches. Also, it has been determinedthat it is preferable for the nozzle to be less than about 0.50 inches.More preferably, the nozzle is less than about 0.3 inches. Even morepreferably, the nozzle is about 0.2 inches long.

In certain embodiments of the invention, the nozzle is a “shaped” nozzledefined by a venturi shaped passageway (see FIGS. 5 and 6). As usedherein, the “venturi shaped passageway” extends the length of the nozzleand is defined by a cylindrical bore 98 that narrows as it approachesthe outlet port 96. The venturi shaped passageway of the nozzle limitsthe generation of turbulence in the irrigation fluid as it passesthrough the nozzle(s) during the operation of the wound irrigationdevice of the subject invention. Therefore, fluid passing through thenozzle experiences laminar flow (or at least a reduction in turbulence)as it passes through and exits the nozzle. Thus, as used herein,reference to the “venturi shaped passageway” refers to a nozzle with apassageway where the cross-sectional area of the inlet port 102 isgreater than the cross-sectional area at or near the outlet port 96 andthe turbulence through the nozzle is less than the turbulence of anozzle of the same or similar size but having a “squared-off” inlet portand/or constant diameter passageway. This venture shaped nozzle has beenfound to be particularly advantageous for achieving desired irrigationfluid pressures and velocities according to the subject invention.

The nozzle passage area 98 is preferably defined by a funnel shapehaving a portion with a curved surface, where the nozzle cross-sectiondecreases from an upstream wider end 102 to the downstream end 96.

FIG. 5 shows a specific embodiment of the elongated, shaped nozzles ofthe subject invention. In FIG. 5 the conical shaped nozzle is 0.2 incheslong (from inlet port to outlet port).

In another embodiment, the elongated nozzles of the invention havenozzle passageways that are defined by a cylindrical shape with straightwalls that lack the curving conical shape.

As would be appreciated by a person skilled in the art having thebenefit of the current disclosure, the nozzles of the subject inventioncan be formed within the material of the discharge means. Thus, if thedischarge means is formed of plastic that is sufficiently thick, thenthe nozzles may simply pass through the material of the discharge means.Alternatively, the nozzles may extend from either side of the dischargemeans. Such an embodiment is shown in FIGS. 3-5.

FIG. 1 shows an embodiment of the subject invention wherein the devicecomprises a squeezable reservoir housing having a wall 60 that forms areservoir that can contain therein an irrigation material (such aswound-cleaning material). The reservoir can preferably hold a liquidsolution (for example, sterile saline) as the wound cleansing solutionfor irrigating, and thereby removing particles or other contaminantsfrom a wound. The reservoir housing has a mouth 62, which communicatesthe reservoir to the outside of the housing. Disposed over the reservoirhousing mouth, and affixed to the reservoir housing mouth is a dischargemeans 80, 100.

Another embodiment of the subject invention includes a reservoir housingcomprising an inlet port and fitting for attaching tubing for deliveryof pressurized gas to the reservoir. Pressure sources generallyavailable in hospitals, emergency rooms, and other medical clinics orfacilities provide a pressure of 0-55 pounds per square inch (PSI). Thereservoir can be attached by, for example, a flexible tube to thepressure source connector and to a fitting provided on the reservoirhousing of the subject device.

In certain embodiments, the discharge means is detachably affixed to thereservoir housing mouth. In such embodiments, the reservoir mouth caninclude connecting means such as threads, snap fits, grooves, or othermechanical connection configurations for operably connecting thereservoir housing mouth to the discharge means.

The wall of the reservoir housing can be made or molded from anymaterial that is preferably rigid enough to stand upright when thereservoir is filled with irrigation solution. In a typical embodiment,the reservoir housing is formed by a molded plastic, which is pliableenough so that the wall of the reservoir housing can be squeezed orcompressed by hand to exert pressure on the contents of the reservoir.The preferred embodiment comprises a plastic material that is pliableenough to squeeze by hand and which also has sufficient resilience toreturn to its original shape when no longer compressed or squeezed.

The horizontal cross-sectional shape of the reservoir housing can becircular, square, rectangular, or other geometric shapes as desired oras already available. The walls can be tapering toward one end or theother. Alternatively, other shapes can be made for the reservoir housingaccording to and adapted for a particular use. For example, part of thereservoir housing wall can be slightly rounded as in a general hourglassshape and/or can be molded for ergonomics to easily fit a hand orotherwise to facilitate handling or compressing the reservoir housing.The reservoir formed by the housing of the subject invention cantypically hold a volume of about 100 ml to 1000 ml, preferably about 250ml to about 750 ml and most preferably about 500 ml. Advantageously,with manual compression, the device and method of the subject inventioncan deliver 500 ml of irrigation fluid in less than 30 seconds and,typically, in 15 to 25 seconds. The fluid is delivered at about 4 to 20psi. Lower pressures can be used for irrigating eye wounds. Forirrigation of wounds in or around the eye, a pressure of about 1 psi toabout 5 psi is preferred.

Further, in a preferred embodiment, the reservoir housing comprises atone end a neck portion formed at the mouth of the reservoir housing. Theneck portion of the reservoir housing is generally at least slightlysmaller in cross sectional area than the reservoir housing. Thereservoir housing neck is preferably integrally molded with thereservoir housing, but can be formed or molded separately and affixed tothe mouth of the reservoir housing. The material used for the neckportion of the reservoir housing can be the same as the material used tomake the reservoir housing cylinder. Alternatively, the neck portion canbe a different material, for example, a more rigid or sturdy materialthan the compressible material forming the reservoir housing wall. Forexample, the material used to make the neck portion can be a metal or ahard plastic, or the like.

With reservoir housing embodiments that include a neck portion, thedischarge means is typically disposed over and affixed to the neckportion. In a related embodiment, the neck portion of the reservoirhousing can include a connecting means for detachably affixing adischarge means thereto. The connecting means can include threads,latches, grooves, or other mechanical connection configurations foroperably connecting the neck portion to the discharge means. Theconnecting means can be on the outer face of the neck portion, forming amale connecting end, or can be on the inner face forming a femaleconnecting end of the neck portion.

In a preferred embodiment, the discharge means has a plurality ofelongated nozzles 70 whereby the irrigation solution in the reservoirpasses through in a pressurized and directional manner. A backsplashshield 90 can also be provided either with the reservoir housing or withthe discharge means.

The back-splash protective shield protects the health care professional(or other user) from back-splash of human and or animal body fluids thatare mixed with and splashed from the wound when the wound is contactedby the discharged irrigation solution.

As described herein, a critical feature of the subject invention is theunique design of the nozzles that enable easy and convenient creation ofa dispersed stream of irrigation solution having the appropriate volume,pressure and dispersal pattern to obtain effective wound irrigation.

As used herein, reference to a “dispersed” stream of solution means thatthe area from which the stream emanates, or the area which it contacts,is larger than that which can be achieved using a typical syringe forirrigation. A typical syringe, as is well known in the art can be, forexample, a 16 or 18 gauge syringe. In one embodiment, the dispersedstream can be achieved using multiple nozzles. The nozzles can bepresented in a variety of patterns on a discharge means, such as acircular or square pattern.

The discharge means with nozzles is a particularly advantageous featureof the invention. The discharge means can be, for example, a flat ordomed disc of approximately the same size as the opening of thereservoir housing. In one embodiment, the discharge means has aplurality of nozzles.

In certain embodiments, the discharge means is designed with connectingmeans that are threads or grooves, which allow for complementaryattachment to currently available irrigation solution bottles. Thus, thedischarge means of the subject invention can be interchangeable, whendesired, with the screw-cap that is provided with an irrigation solutionbottle as are available. The screw-top design of the discharge meansprovides the operator with the option of using the reservoir housingwith the nozzles of the invention or to threadably remove the dischargemeans and pour out or change the irrigation solution.

Each of the nozzles of the discharge means can be of any desirable size,preferably less than one-eighth inch in diameter and having a sizebetween about a 10 gauge hypodermic needle and about a 30 gauge needle,and most preferably having a size ranging from that of a 16 gauge needleto a 25 gauge needle. Specific dimensions and shapes are shown in FIG.5. The outlet port 96 may have, for example, an inner diameter of about0.02 to about 0.07 inches. For the venturi shaped nozzle (FIG. 6), thediameter of the inlet port 102 (proximal to the reservoir) can be, forexample, from about 0.05 to about 0.30 inches, or more.

Each of the nozzles can be the same size or the nozzles can be differentsizes and shapes. The different sizes of nozzles allow for the liquid tobe expelled from the discharge means at different pressures. Forexample, the 16 gauge nozzle allows for a stream having about 6 psipressure when the device is squeezed by the normal adult; the 25 gaugenozzle provides a pressure of up to about 20 psi from each nozzle.

The shaped nozzles of the invention have the added advantage whencompared to other nozzles in that little or no release of irrigationmaterial is permitted without pressure being applied to the irrigationmaterial. For example, if a reservoir housing with shaped nozzles istipped onto its side or even held upside-down with gravitational pull onthe irrigation material through the discharge means, there will belittle or no release of irrigation material through the shaped nozzles.

As shown in FIG. 2, one embodiment of the subject invention alsoincludes a removable or partially detachable protective cap 92, which isplaced over the discharge means to protect the nozzles and contents ofthe reservoir from contamination or premature discharge or leakage. Theprotective cap can be attached with an element 94 that is removable.Such elements 94 include fasteners, non-permanent adhesives, and thelike.

In a preferred embodiment, the discharge means 70 comprises fournozzles. Additionally, to discharge the irrigation solution atappropriate pressure, the diameter of the nozzles 74 can be about 0.02to 0.07 inches in diameter.

The irrigation solution used can be water, saline, or a balanced saltsolution. The solution is preferably sterile and at the discretion ofthe user or manufacturer of the irrigation solution can additionallycomprise an antibacterial and/or antifungal component. The device can besterilized by known sterilization techniques, including boiling,autoclaving, gas sterilization and the like, either separately ortogether with the reservoir housing.

Buffered Ringer's solution or commercially available balanced saltsolution (e.g., Tis-U-Sol or Physio-Sol) are physiologically compatibleand are commonly used in wound irrigation procedures.

The antiseptic agents most commonly used in wound care at presentinclude:

Povidone-iodine solution (Betadine preparation)—iodine added to thecarrier polyvinylpyrrolidone (PVP), a water-soluble organic complex;this combination is called an iodophor. Standard solutions of Betadinepreparation are 10 percent.

Povidone-iodine surgical scrub (Betadine scrub)—the iodophor PVP-I andan anionic detergent (pH 4.5).

pHisoHex—an emulsion of an anionic detergent, entsulfon, lanolincholesterols, petrolatum, and hexachlorophene (pH 5.5).

Hi-Bi-clens—chlorhexidine gluconate plus a sudsing base (pH 5.1 to 6.5).

Tincture of green soap—potassium oleate, isopropanol, potassium coconutoil, soap.

Dakin's solution 0.2 percent solution hypochlorite solution.

Hydrogen peroxide—an oxidizing agent.

Benzalkonium chloride (Zephiran)—a quaternary ammonium compound thatworks as a cationic surface active agent.

Nonionic surfactants—Pluronic F-68 (Shur-Clens) and Poloxamer-188(Pharma Clens)-agents that have no antimicrobial activity (pH 7.1).

From the description of the device herein above, a method of using thesubject device would readily be understood and adaptable by thosepersons having ordinary skill in the art. The reservoir housing isfilled with a desired irrigation solution. The irrigation solution issterilized before or after filling. The reservoir housing and contentscan be stored in a sterile environment, e.g., sterile packaging which isopened immediately prior to use. In a preferred use, the protectiveshield is removed, then the reservoir housing can be directed towardsthe wound and squeezed or compressed to expel or discharge the solutionin the desired direction, and at the desired pressure to effectirrigation of a wound to remove contaminants or debris. See also theExample 2, provided below.

It would also be understood that the described discharge means can bepackaged separately from the reservoir housing. The discharge means ispackaged in a sterile environment. In a preferred use of the embodimentwherein the discharge means is provided separately from the reservoirhousing, the cap of a readily available, squeezable irrigation bottlecontaining a sterile irrigation solution, e.g., normal saline, isreplaced with the subject discharge means. The bottle, now having thesubject discharge means attached or engaged thereto, can be used asdescribed herein.

In one embodiment, the discharge means is provided in a sterilelaceration tray. According to the subject invention, the laceration trayhas, in addition to a discharge means or entire irrigation bottle of thesubject invention, other items conveniently provided for treatingwounds. Contemplated items that can be included in a laceration trayinclude, but are not limited to, needle holders (i.e., 5″ floor-gradesmooth); scissors (i.e., 4.5″ floor-grade straight Iris scissors);hemostats (i.e., 5″ floor-grade curved mosquito hemostat); forceps(i.e., floor-grade tissue forceps with 1×2 teeth); cups (i.e., 2 oz.medicine cups); syringes (i.e., 10 cc Luer Lock syringe); needles (i.e.,25 gauge×⅝″ needle; 27 gauge×1.5″ needle; 18 gauge×1.5″ needle);dressings (i.e., gauze dressings); drapes (i.e., polylined fenestrateddrapes); and towels (i.e., absorbent towels).

Another embodiment of the invention provides a pressurized irrigationassembly to provide automated dispersal of irrigation solution. Thepressurized irrigation assembly can comprise: irrigation solution; areservoir housing that contains the irrigation solution; a dischargemeans having a plurality of specifically designed nozzles through whicha sufficient volume of the irrigation solution can pass at anappropriate pressure; a means for creating irrigation solution pressurefor the generation of a plurality of dispersed streams through thenozzles to irrigate damaged tissue.

A variety of pressure means have been developed to enable automatic (asopposed to manual) transfer of irrigation solution from a reservoirhousing to damaged tissue. For example, U.S. Pat. No. 6,574,527 toHenniges et al. describes a hand held irrigator that can be attached tothe mouth of a reservoir housing irrigation solution. Various otherapparatus that enable the automatic transfer of irrigation solution froma reservoir housing to damaged tissue include, but are not limited to,U.S. Pat. Nos. 6,751,813; 6,746,419; 6,106,494; 5,484,402; 5,470,305;5,269,750; and 5,046,486.

In one embodiment of the invention, the pressure means is a hand-helddevice similar to the irrigator disclosed in U.S. Pat. No. 6,754,527.The hand held device has a tip and a supply end. Irrigation solutionfrom the reservoir housing is provided to the supply end of the pressuremeans and is eventually discharged from the tip of the pressure means.Affixed to the tip is a discharge means of the invention, which can bedetachably affixed to the tip. The hand held device further comprises apump for regulating the rate of irrigation solution discharge and amotor for actuating the pump. In certain embodiments, the motor is abattery operated motor.

In a method of use, where a reservoir housing 60 having discharge means70 affixed thereto is provided, a protective cap 92 is first removedfrom the backsplash shield 90. The discharge means 70 is directedtowards the wound, and the reservoir housing 60 is compressed,discharging the irrigation solution through the discharge means 70. Thesolution can be discharged at a range of pressures of about 4-20lbs/in², with a preferred pressure of about 7 psi.

The reservoir housing 60 can be compressed manually or via othermechanical means. For example, the operator may compress the reservoirhousing using either one hand or two hands, to provide increasedpressure (i.e., 16 psi). Alternatively, a pressure means can beactivated to generate a dispersed stream of irrigation solution throughthe discharge means.

In another method of use, where a reservoir housing 60 and dischargemeans 70 are provided separately, a protective cap 92 is removed fromthe mouth or neck portion of the reservoir housing. The discharge meansis then affixed to the mouth or neck portion of the reservoir housingvia complementary connecting means. After the discharge means is affixedto the reservoir housing, the discharge means is directed towards thewound or eye, and the reservoir housing is compressed to discharge adispersed stream of irrigation solution through the nozzles of thedischarge means.

Significantly, it is known that more force is required to rid the woundof particles with a small surface area (e.g., bacteria) than to removeparticles with a large surface area (e.g., dirt, sand, or vegetation).Minimum recommended volumes of irrigation solution vary, but for amoderately sized potentially contaminated wound, for example alaceration 3-6 cm long and less than 2 cm deep, at least 200 to 500 ml,or more should be used. Greater volumes, on the order of one to twoliters, may be required for larger or heavily contaminated wounds.Irrigation should continue at least until all visible, loose particulatematter has been removed.

Following are examples that illustrate procedures for practicing theinvention. These examples should not be construed as limiting.

EXAMPLE 1 Preferred Nozzle Designs

Performance of nozzle designs with regard to pressure, flow rate anddynamic pressure, were compared.

In one test, a squeeze bottle with inlet fitting and pressurizedreservoir was set up on its side and filled. A flow meter was placedbetween the squeeze bottle and the reservoir. A test pressure range of2-7 psi was applied to each nozzle design and the flow rate was recordedfor each test pressure (1 psi increments).

The shaped nozzle design (defined by a venturi shaped passageway)created greater flow than the sharp edged, non-shaped nozzle at the samefluid pressure.

For a pressure test, a fulcrum and scale were set-up in front of thehorizontally mounted irrigation device. The pressure to the nozzles wasvaried from 2 to 7 psi and the force was recorded at each 1 psiincrement.

The shaped nozzle produces between 70%-200% more force than thesharp-edged nozzle.

At 4 psi the calculations show 25.7 and 19.2 grams of force for theshaped and non-shaped nozzles, respectively.

Thus, the discharge means with 4-venturi shaped nozzles produces moreforce and more flow per squeeze on the irrigation bottle than thedischarge means with 4 non-shaped nozzles.

EXAMPLE 2 Methods of Wound Irrigation

When a patient presents a wound to a medical or other health careprofessional skilled in the art, that medical professional assesses theextent of the injury sustained by the patient, including all other lifethreatening injuries. Appropriate action regarding these lifethreatening injuries is performed and a history is recorded. All woundsare covered to minimize further contamination until the actual repairprocess begins.

For examination of the wound, it is assumed that a medical professionalwould have performed a detailed evaluation of the extent of tissueinjury, including but not limited to: anatomical area considerations,depth of the wound, type of injury, e.g., crash injury, puncture wound,bites, missiles, cuts with sharp objects, or the like. Included in thisexamination would be a determination of the type(s) of contamination,time elapsed between the occurrence of the injury to presentation, grosscontamination of a wound, and other medical factors associated with anincrease incidence of infection (for example, diabetics, AIDS patients,and chemotherapeutics patients).

The wound and surrounding tissue, at the option of the health careprofessional, could be anesthetized using topical, local, or generalanesthetics before the wound-cleansing method begins.

In one embodiment, the subject device has a discharge means affixed to areservoir housing as described with a protective shield covering thedischarge means. The health care professional using the subject devicewould remove the protective shield to expose the discharge means. Thesubject device can be held in either hand as preferred by the user.Normally, it would be held in the dominant hand in a bottle-holdingfashion. This allows the medical care professional to gently open thewound if needed, with the opposite hand, preferably protected by asterile glove, to expose the depths of the wound.

Once the depths of the wound have been exposed, the end of the reservoirhousing having the discharge means affixed thereto is directed towardsthe wound. Manual or mechanically produced pressure is applied to thereservoir housing to expel the irrigation solution through the nozzlesof the discharge means. The wound should be irrigated in this fashionuntil all visible evidence of contamination has been removed. Apotentially contaminated wound of any size should be irrigated with aminimum of 200-300 ml of irrigation solution. Heavily contaminated orlarger wounds may require 2-3 liters of irrigation solution. The healthcare professional could vary the angle of the discharged irrigationsolution from the discharge means in reference to the wound to furtherassist with the dislodgement of contaminants. This variation in theangle will also decrease or increase the amount of back-splash. Thus itwould be important to irrigate in a manner that decreases theback-splash. Minimizing back-splash is achieved by irrigation at acuteangles to the plane of the wound.

Following an initial irrigation of the wound, a re-examination of thewound should be undertaken. The wound should be explored to its base toascertain that no visible foreign bodies or contaminants remain. Ifforeign bodies or contaminants are found, the irrigation process shouldbe repeated followed by a re-examination. This may continue for severalcycles.

Once irrigation has been completed, i.e., no visible contaminantsremain, the damaged tissue would be repaired in a standard acceptedfashion.

Irrigation of skin wounds such as cuts, scrapes, punctures, abrasions,etc. are particular well-suited for irrigation according to the subjectinvention.

It should be understood that the example and embodiment described hereinis for illustrative purposes only and that various modifications orchanges in light thereof will be suggested to persons skilled in the artand are to be included within the spirit and purview of this applicationand the scope of the appended claims.

1. A device for wound irrigation wherein said device comprises areservoir housing containing a sterile wound irrigation solution, andwherein said reservoir housing is attached to a discharge means havingat least one nozzle through which the wound irrigation solution can exitthe reservoir housing, wherein said nozzle has a cross-sectional areathat decreases from the inlet port of the nozzle (proximal to thereservoir housing) to the outlet port (distal to the reservoir housing)such that the nozzle forms a venturi passageway.
 2. The device,according to claim 1, wherein the nozzle has a length from the inletport to the outlet port of between about 0.005 and 0.50 inches.
 3. Thedevice, according to claim 2, wherein the nozzle has a length of betweenabout 0.01 and 0.3 inches.
 4. The device, according to claim 1, whereinthe inner diameter of the outlet port is between about 0.02 and 0.07 andthe inner diameter of the inlet port is between about 0.05 and 0.30inches.
 5. The device, according to claim 1, further comprising abacksplash shield.
 6. The device, according to claim 1, wherein thereservoir housing is made from a compressible material.
 7. The device,according to claim 6, wherein the reservoir housing is made fromplastic.
 8. The device, according to claim 1, wherein the reservoirhousing is generally in the shape of a cylinder having an ergonomicshape with curved sides such that the cross-sectional area of thecylinder varies along the length of the cylinder.
 9. The device,according to claim 1, further comprising means for pressurizing thereservoir housing.
 10. The device, according to claim 8, wherein themeans for pressurizing the reservoir housing is battery operated. 11.The device, according to claim 1, having a plurality of nozzles.
 12. Thedevice, according to claim 11, having 4 nozzles.
 13. The device,according to claim 1, which creates a dispersed stream of irrigationfluid when the irrigation fluid leaves the device under pressure. 14.The device, according to claim 1, which has approximately 500 ml ofirrigation solution.
 15. The device, according to claim 14, wherein,when the device is placed on its side, fluid does not exit the nozzles.16. The device, according to claim 1, which is sterile and enclosedwithin a wrapper that maintains sterility until the wrapper is opened.17. A tray conveniently providing items for use in treating woundswherein said tray comprises at least one of the following: a) adischarge means that can be attached to a bottle containing woundirrigation solution; or b) a bottle containing a wound irrigationsolution, and wherein said tray further comprises at least one itemselected from the group consisting of: needle holders; scissors;hemostats; forceps; cups; syringes; needles; dressings; drapes; andtowels.
 18. A method for irrigating a wound, said method comprising thefollowing steps: (a) providing a device for wound irrigation whereinsaid device comprises a reservoir housing containing a sterile woundirrigation solution, and wherein said reservoir housing is attached to adischarge means having at least one nozzle through which the woundirrigation solution can exit the reservoir housing, wherein said nozzlehas a cross-sectional area that decreases from the inlet port of thenozzle (proximal to the reservoir housing) to the outlet port (distal tothe reservoir housing) such that the nozzle forms a venturi passageway;(b) directing the discharge means and reservoir housing so as todischarge the wound-irrigation solution toward a wound; and (c)discharging said wound-irrigation solution from said reservoir housingand through said nozzle, or nozzles, to produce a stream ofwound-irrigation solution directed at the wound.
 19. The method,according to claim 18, wherein said wound-irrigation solution isdischarged from said device, at a pressure between about 4 psi and about20 psi.
 20. The method, according to claim 18, wherein said dischargemeans has a plurality of nozzles.
 21. The method, according to claim 20,wherein said discharge means has 4 nozzles.
 22. The method, according toclaim 18, wherein the inner diameter of the outlet port of the nozzle,or nozzles, is between about 0.02 and about 0.07 inches.
 23. The method,according to claim 18, wherein the inner diameter of said inlet port(s)is between about 0.05 and 0.30 inches.
 24. The method, according toclaim 18, wherein said discharge means is detachably engaged to saidreservoir housing.
 25. The method, according to claim 18, wherein saiddevice comprises a backsplash shield.
 26. The method, according to claim18, wherein the nozzle has a length of between about 0.01 and 0.50inches.
 27. The method, according to claim 18, wherein the irrigationfluid leaving the device creates a dispersed stream of fluid.
 28. Themethod, according to claim 18, wherein about 500 ml of fluid isadministered in about 15 to 30 seconds.
 29. The method, according toclaim 18, wherein the wound is in or around the eye and the irrigationfluid is administered at a pressure of from about 1 psi to 5 psi.
 30. Adischarge means that can be attached to a reservoir housing thatcontains an irrigation fluid, where said discharge means has at leastone nozzle through which the wound irrigation solution can exit thereservoir housing, wherein said nozzle has a cross-sectional area thatdecreases from the inlet port of the nozzle (proximal to the reservoirhousing) to the outlet port (distal to the reservoir housing) such thatthe nozzle forms a venturi passageway.